gcsr sem 4
DESCRIPTION
123TRANSCRIPT
A. Description of Business
GUJARAT LIQUI PHARMACAPS (PVT) LIMITED (GLPL) is a leading Indian
Pharmaceutical company specializing in Novel Drug Delivery System of Soft Gelatin
Capsules & having its state-of-the-art Manufacturing Facility at Gujarat, India. We are an
Export Oriented WHO approved, ISO 9001: 2008 for Quality Management Systems
& ISO 14001: 2004 for Environmental Management Systems certified company with
STAR EXPORT HOUSE STATUS. We have been awarded the prestigious SME
GAURAV AWARD-2011, instituted and given by D&B and Axis Bank for
Entrepreneurial Excellence in Business, Operations, Finance and Quality of the
Management.
We manufacture, market and distribute these Formulations, some of them being life
saving, around the world. In addition, we have our foray in other dosage forms as well.
Our special focus on Research, Development of new formulations and validating their
Methods of Analysis have made us so unique in Soft Gels in such a short time in the
rapid changing scenario of Pharmaceutical world. We played a pioneering role in
developing some of the formulations for the first time in the world in Soft Gelatin dosage
form. We have got our global presence around the world.
As an Organization, we attach immense importance and significance to learning and
being emotionally intelligent. We also want us to be seen and known as an institution
genuinely supporting multi-racial harmonious co-existence and living our lives with
paradigms shifted and boundaries of limitations removed!
Like Dr. Kalpana Chawla, we also believe “The path from dreams to success does exist”,
we hope that “you have the vision to find it, courage to get on to it and the perseverance
to follow it”.
Our Vision
Be global and remain local.
Build a motivated institution of competent persons and expand our knowledge
base.
Strive relentlessly for excellence in every sphere of our activities through
continual up-gradation of knowledge.
Nurture environment, conserve energy and support human lives with our serious
healthcare efforts.
Our Mission
Business Excellence : Through delighted Customers with long term Win-Win-
Win relationships and Technological innovations.
Nurturing Human Assets : By providing an open and challenging Working
Environment charged with Passion and aided by Emotional Intelligence.
Responsible Corporate Citizenship : Through Conservation of Energy and
providing support to our Mother Nature
Our Business
We have dedicated our business initiatives to a Novel Drug Delivery System i.e.
Soft Gelatin Pharmaceutical Formulations having immense unexplored potential
for offering better drug efficacy in alleviation of human suffering and misery.
Our business is structured mostly in following 02 categories.
Exports :
Have our Sales & Marketing offices in different countries of Africa, South East
and Central Asia and also operate for our buyers in UK, Arab world and South
America.
Domestic :
We have got limited but significant operational presence for ethically Marketing,
Selling and Distributing our Medicines in Indian states of Gujarat, MP &
Chattisgarh and Rajasthan.
We also outsource Pharmaceutical formulations of other Dosage Forms like
Tablets, Capsules, Injectibles and ointments and market them under our strict
Quality Control Vigilance.
Very strong Formulation Developmental initiatives support and reinforce our
Business Operations.
SWOT analysis of the company:
Strength
Technological skill
Leading brands
Production quality
Focus only Gelatine Capsules
only
Wide international market
Vast market growth potential
Strong local manufacturing
sector
Strong brand presence in
African market
Good marketing and
distribution system
Weakness
High transaction costs
Weak focus on process
innovations
High computation from
many Indian and other
global brands.
Lack of data protection
Opportunities
Liberalization of geographic markets
Changes in government politics
Entering into domestic market
Rising demand for generic drugs
globally
Venturing towards areas of
cardiology and anti-cancer
Scope for expansion and additional
units for generic drugs.
Threats
There is growing
competition in generics
market
Highly regulated industries
Products are highly
immitigable
Price of row material
fluctuate highly
B. Products of the company:
Product
Name
Composition Photograph
Artequin
Contains:
Amodiaquine Hydrochloride USP Equivalent to Amodiaquine Base 153.1 mg
12 Nos. Amodiaquine Capsule
Each Soft Gelatin Capsule Contains:
Artesunate 50 mg
Packing Style
12 + 12 Capsules
Mantra Plus
Contains:
Acetaminophen USP 500 mg
Caffeine USP 25 mg
Excipients Q.S.
Packing Style
1×10 Capsules
Emprofen 400
Contains:
Ibuprofen BP 400 mg
Excipients Q.S.
Packing Style
1×10 and 10×10 Capsules
Emprofen
200
Contains:
Ibuprofen BP 200 mg
Excipients Q.S.
Packing Style
1×10 Capsules
Parcamol
Forte
contains:
Acetaminophen 500 mg
Caffeine 25 mg
Packing Style
10 Capsules
Tegaferol
contains:
Alpha Lipoic Acid 100 mg
Packing Style
10 x 10 Capsules
Helicoban
Contains:A. 2 Nos. OMEPRAZOLE CAPSULES Each soft gelatin capsule contains:Omeprazole BP 20.0 mgExcipients Q.S.
B. 2 Nos. CLARITHROMYCIN CAPSULESEach soft gelatin capsule contains:Clarithromycin USP 250.0 mgC. 2 Nos. TINIDAZOLE CAPSULESEach soft gelatin capsule contains:Tinidazole BP 500.0 mg
Packing Style 7 x (2+2+2) Capsules
C. Market Analysis & Marketing Plan
Segmentation
There are five major segments in GLPL.
1. Anti- Bacterial
2. Anti-Malarial
3. Haematinics
4. Pain Management
5. Herbal Formulation
4Ps analysis
Product
Artequin
Price
Place
South Africa, Nigeria, Morocco
Promotion
1. Publish their brochure in countries
market
2. Publish their calendar in the market
3. Campaign near hospital and health care
centre
4. Distribution of Complementary gifts
Import/export policies & procedures for selected product/service.
1. Import/Export Norms
Legal considerations
All transactions concerning the importation of consignments of pharmaceutical products should
be conducted through Ministry of Health, mission hospitals, any other person authorised by the
DRA or through independent authorised pharmaceutical importers licensed by the relevant drug
regulatory authority for this purpose.
The importation of all consignments of pharmaceutical products should be channelled
exclusively through the designated ports of entry and will be cleared by customs in consultation
with the inspectorate of the respective DRA.
An application for the issue of an import or export permit shall be made by an authorised
importer to the respective Drug Regulatory Authority in a prescribed form.
An applicant for an import permit must be in possession of an import licence issued by the
relevant drug regulatory authorities. The validity of the licence shall be determined by the
respective Drug Regulatory Authority. The Pharmaceutical Import Licence shall be subject to
renewal upon expiry.
No importation or exportation of pharmaceutical products shall be done by post.
The importation and exportation of Medicines and Scheduled substances are subject to control in
terms of the provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) as
amended. South Africa is also a signatory to three International Drug Conventions, namely:
• The Single Convention on Narcotic Drugs, 1961;
[The Medicines Control Council is responsible for implementing the measures required by the
said convention]
• The Convention on Psychotropic Substances, 1971; and
[The Medicines Control Council is responsible for implementing the measures required by the
said convention]
• The United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic
Substances, 1988.
[The Department of Trade and Industry is responsible for implementing the measures required
by the said convention]
Implementation of controls
The drug regulatory authorities shall provide comprehensive and frequently updated lists of
licensed or notified medicinal products and authorised dealers/importers which should be easily
accessible to designated ports of entry and authorised dealers. Notifications on any product
licences that have been withdrawn on grounds of safety or quality and confirmed cases of
imported counterfeit products and other illicit activities should immediately be communicated to
all the DRAs.
Customs officials in collaboration with a pharmaceutical inspector will carry out physical
examination of all imported consignment of medicinal products and their documentation.
Where necessary, the pharmaceutical inspector will carry out random sampling of
pharmaceutical products in accordance with laid down guidelines on sampling of medicinal
products imported into the country for drug analysis.
Consignments of pharmaceutical products should be accorded high priority for clearance through
ports of entry. Since pharmaceutical products tend to degrade on storage and some need to be
kept in cold storage, ports of entry need to be provided with secure storage facilities including
refrigerated compartments.
The authorised importer should alert customs officials in advance of the anticipated arrival of
consignments in order that they can be transferred to the designated storage facilities without
breaking the cold chain.
Required Documents
The import and export authorisations shall contain at least the following
information:
name of controlled substance(s) (if available, the International Nonproprietary Name)
quantity to be imported/exported expressed in terms of anhydrous base content.
name & address of the importer and exporter.
period of validity of the authorisation.
route of entry/exit through which importation/exportation shall be effected.
number and date of the corresponding import/export authorisation and the name of the
competent authorities of the importing/exporting countries by whom it was issued.
strength and dosage form.
An application for a licence to import/export controlled substances will be made to the respective
Drug Regulatory Authorities in the prescribed form backed by legislation.
Criteria for issue of authorisation to import
there are suitable premises, facilities and equipment for proper pharmaceutical
warehousing.
there are suitably qualified pharmaceutical personnel that shall oversee the quality
assurance i.e. pharmacist and pharmacy technologist/technician.
there are suitable arrangements, programmes and systems for procurement, storage,
documentation, stock surveillance and distribution.
Application for issue of an import permit
An application accompanied by a prescribed fee for issue of an import permit shall be made on
the prescribed form backed by legislation.
An application for issue of an import permit shall state, for each medicine to be imported at least
the following:
generic name or International Non-proprietary Name (INN)
strength and dosage form
name and strength of each ingredient; in case of a product containing more than
one ingredient
trade name or proprietary name; if any
pharmacopoeia specification of the medicine, where applicable
total quantity to be imported
name and address of the supplier
name and address of the manufacturer
country of origin
route of entry
licence/ registration number
cost, insurance, freight (CIF) value
expected date of arrival
A separate import permit for controlled substances will apply as prescribed by the national
legislation and applicable treaty obligations. The application shall be accompanied by copies of
the proforma invoices.
Application for issue of an export permit
An application accompanied by a prescribed fee for issue of an export permit shall be made on
the prescribed form backed by legislation. An application for issue of an export permit shall
state, for each medicine to be exported at least the following:
generic name or International Non-proprietary Name (INN)
strength and dosage form
name and strength of each ingredient; in case of a product containing more than
one ingredient
trade name or proprietary name; if any
pharmacopoeia specification of the medicine, where applicable
total quantity to be exported
name and address of the exporter
name and address of the manufacturer
name and address of consignee
country of consignee
route of dispatch
licence/registration number
cost, insurance, freight (CIF) value
expected date of dispatch
The application shall be accompanied by copies of the purchase orders.
In conclusion, importation of drugs that lack approval and are not in line with these guidelines
whether for personal use or otherwise will be considered as illegal importation and could be
refused entry into any of the SADC countries or seized by customs officials.
Licence No.
Registration No.
Pharmaceutical Import Licence
Messrs (Name of Importer)………………………………………………………………….........
………………………………………………………………………………………………………
……………………………………..
of (address i.e. Plot No. Street/Road, Town/City. P.O. Box) ……………………….…..
……………………………………..
………………………………………………………………………………………………………
…………………...…..…..…..
…………………………………………………………………………………………………….
………………………….…………………...
Carrying on business as ………………………………………………..….………….
……………..…………………… ………...
Are hereby authorised to Import Pharmaceutical Products (Medicines, herbal medicines
and allied substances) into the Country during the calendar year……………………..
…………………..……………………………………….……………..
Name of Supervising Pharmacist …………………………………………………..
Registration Certificate No: ………………………………………………..
Conditions imposed by the Pharmaceutical Regulatory Authority (refer to notes overleaf).
This licence is valid from……….. to…
………………. ……………..
Registrar of medicines Date stamp
Date Issued ………………………….
Licence No.
Registration No.
Pharmaceutical Export Licence
Messrs (Name of Exporter)……………………………………………………………… ……..
……………….
………………………………………………………………………………………………………
……………………………………..
of (address i.e. Plot No. Street/Road, Town/City. P.O. Box)…………………….
…………………………………………………..……………………………………………….
………………………………………………………………………………………………………
………………………………………………………………..
…………………………………………….…………………...
Carrying on business as ……………………… ……………………………………….
……………..………………………………...
Are hereby authorised to export Pharmaceutical Products (Medicines, herbal medicines
and allied Substances) during the calendar year…………………………..
……………………………………….……………..
Name of Supervising Pharmacist …………………………………………………..
Registration Certificate No: ………………………………………………..
Conditions imposed by the Drug Regulatory Authority (refer to notes overleaf).
This licence is valid from…………. to………….………………….
………………. ……………..
Registrar of medicines Date stamp
Date Issued …………….……